Effect of Eurycoma longifolia water extract (Physta®) on menopausal quality of life and mood states

Table 1 Baseline sociodemographic characteristics of study participants by group

Characteristic	Placebo (n = 40)	Physta® 50 mg (n = 36)	Physta® 100 mg (n = 36)	Total (n = 112)
Age
40-44	8 (20)	12 (33)	11 (31)	31 (28)
45-49	24 (60)	14 (39)	16 (44)	54 (48)
50-55	8 (20)	10 (28)	9 (25)	27 (24)
Ethnicity Malay	38 (95)	36 (100)	34 (94)	108 (96)
Chinese	0 (0)	0 (0)	1 (3)	1 (1)
Indian	2 (5)	0 (0)	0 (0)	2 (2)
Others	0 (0)	0 (0)	1 (3)	1 (1)
Education level Secondary school	5 (12)	9 (25)	4 (11)	18 (16)
Certificate/diploma	16 (40)	11 (31)	10 (28)	37 (33)
Degree	19 (48)	16 (44)	22 (61)	57 (51)
Working status
Not working	3 (7)	9 (25)	5 (13)	17 (15)
Working	37 (93)	27 (75)	31 (87)	95 (85)

Data are presented as n (%).

Table 2 Data of menopause-specific quality of life and profile of mood states of Physta^® 50 mg, 100 mg, and placebo at baseline, week 6 and week 12

Parameter	Placebo (n = 40)			Physta® 50 mg (n = 36)			Physta® 100 mg (n = 36)
	Baseline	Week 6	Week 12	Baseline	Week 6	Week 12	Baseline	Week 6	Week 12
MENQOL
Vasomotor	3.12 ± 1.80	2.59 ± 1.60b	2.41 ± 1.27c	3.35 ± 2.12	2.43 ± 1.32b	2.51 ± 1.49	3.68 ± 2.09	2.94 ± 1.74b	2.45 ± 1.67d
Psychosocial	3.12 ± 1.36	2.49 ± 1.33b	2.61 ± 1.22d	3.00 ± 1.48	2.53 ± 1.34b	2.51 ± 1.43d	3.62 ± 1.60	2.75 ± 1.22b	2.65 ± 1.47d
Physical	3.98 ± 1.27	2.91 ± 1.22b	2.93 ± 1.48d	3.94 ± 1.18	2.96 ± 1.14b	2.85 ± 1.37d	4.45 ± 1.15	2.99 ± 1.12b	2.83 ± 1.33d,f
Sexual	3.38 ± 1.94	2.58 ± 1.44b	2.69 ± 1.46c	3.53 ± 1.76	2.81 ± 1.34a	2.65 ± 1.46d	3.94 ± 1.86	2.69 ± 1.51b	2.51 ± 1.46d,f
Total MENQOL	104.95 ± 35.48	79.53 ± 33.43b	80.45 ± 37.27d	104.67 ± 33.39	80.72 ± 31.25b	78.58 ± 38.15d	119.11 ± 35.52	83.92 ± 32.42b	78.75 ± 37.64d,f
POMS
Tension	9.03 ± 4.81	8.10 ± 5.10	8.33 ± 4.69	10.14 ± 5.69	9.44 ± 5.02	9.03 ± 5.17	10.89 ± 6.34	9.92 ± 6.61	8.53 ± 5.19c
Depression	9.05 ± 8.16	7.85 ± 10.47	8.03 ± 9.37	10.28 ± 11.55	10.97 ± 10.96	9.72 ± 9.60	13.17 ± 12.98	11.39 ± 12.08	8.97 ± 9.60d
Anger	9.45 ± 6.98	8.08 ± 8.49	8.25 ± 6.92	10.36 ± 8.33	10.36 ± 8.28	9.33 ± 8.11	12.50 ± 9.14	10.83 ± 10.00	10.78 ± 11.85
Vigor	17.70 ± 3.98	18.25 ± 4.87	19.20 ± 4.86	19.00 ± 5.74	18.83 ± 6.10	19.22 ± 5.35	17.06 ± 5.24	18.38 ± 4.96	18.03 ± 4.97
Fatigue	8.73 ± 4.97	6.30 ± 5.45b	6.20 ± 5.36d	9.14 ± 5.91	7.58 ± 5.28	6.25 ± 5.14c	11.36 ± 6.07	7.50 ± 5.80b	7.17 ± 8.17d
Confusion	7.97 ± 4.18	6.55 ± 4.15a	6.95 ± 3.86	7.36 ± 4.28	7.50 ± 4.14	6.64 ± 3.87	8.42 ± 4.80	7.36 ± 5.03	6.69 ± 4.28c
Total mood disturbance	26.53 ± 27.30	18.63 ± 31.63	18.55 ± 28.88	28.28 ± 34.66	27.03 ± 31.50	21.75 ± 30.06	39.28 ± 37.61	28.72 ± 37.12a	24.11 ± 35.48d

^aP < 0.05 from baseline to week 6.

^bP < 0.01 from baseline to week 6.

^cP < 0.05 from baseline to week 12.

^dP < 0.01 from baseline to week 12.

^fP < 0.05 for Physta^® 100 mg vs placebo.

Data are presented as mean ± SD scores for menopause-specific quality of life and profile of mood states parameters across placebo, Physta^® 50 mg, and Physta^® 100 mg groups at baseline, week 6, and week 12. Mixed analysis of variance was used to assess time-by-group interaction effects, and paired and independent t-tests were used for within-group and between-group comparisons, respectively. MENQOL: Menopause-specific quality of life; POMS: Profile of mood states.

Table 3 Summary of symptoms reported, n (%)

Adverse event	Placebo (n = 40)	Physta® 50 mg (n = 36)	Physta® 100 mg (n = 36)	Total (n = 112)	Severity	Outcome	Related to product
Bloating	2 (5.0)	3 (8.3)	4 (11.1)	9 (8.0)	Mild	Resolved	No
Headache	1 (2.5)	2 (5.6)	2 (5.6)	5 (4.5)	Mild	Resolved	No
Breast tenderness	0 (0.0)	1 (2.8)	2 (5.6)	3 (2.7)	Mild	Resolved	No
Flatulence	1 (2.5)	2 (5.6)	2 (5.6)	5 (4.5)	Mild	Resolved	No
Abdominal discomfort	1 (2.5)	1 (2.8)	2 (5.6)	4 (3.6)	Mild	Resolved	No
Total events	5 (12.5)	9 (25.0)	12 (33.3)	26 (23.2)	-	-	-

Table 4 Data of anthropometry measurements, vitals, and safety of Physta^® 50 mg, 100 mg and placebo at baseline, week 6, and week 12

Parameter	Placebo (n = 40)			Physta® 50 mg (n = 36)			Physta® 100 mg (n = 36)
	Baseline	Week 6	Week 12	Baseline	Week 6	Week 12	Baseline	Week 6	Week 12
Anthropometry
BMI (kg/m2)	26.35 ± 2.59	26.77 ± 2.92	26.91 ± 3.12a	26.05 ± 2.95	26.48 ± 3.29	26.49 ± 3.20 a	26.71 ± 2.71	27.00 ± 2.81	26.93 ± 2.73a
Height (cm)	157.25 ± 4.85	157.22 ± 4.93	157.14 ± 4.92	155.74 ± 6.27	155.30 ± 6.30	155.65 ± 6.25	156.20 ± 4.96	156.00 ± 4.95	156.10 ± 5.05
Weight (kg)	65.33 ± 8.62	66.35 ± 9.41	66.66 ± 9.91a	63.29 ± 9.09	63.94 ± 9.40	64.31 ± 9.60 a	65.24 ± 7.94	65.78 ± 8.07	65.67 ± 7.69a
Vitals and safety
SBP (mmHg)	123.80 ± 16.33	120.02 ± 15.85	122.98 ± 14.43	121.53 ± 13.38	121.19 ± 14.34	121.47 ± 12.39	126.36 ± 11.47	124.72 ± 14.70	123.11 ± 12.59
DBP (mmHg)	79.83 ± 9.11	76.85 ± 8.82	77.90 ± 9.12a	80.44 ± 11.27	78.47 ± 9.11	79.92 ± 9.40a	82.53 ± 7.86	79.03 ± 8.94	79.00 ± 10.15a
Pulse rate	73.73 ± 10.09	74.75 ± 12.15	77.90 ± 12.60	74.53 ± 7.17	71.75 ± 11.95	72.50 ± 7.88	72.78 ± 7.08	72.58 ± 7.66	73.58 ± 9.86
Urea	3.66 ± 0.84	3.68 ± 0.99	3.60 ± 0.81	3.68 ± 0.71	3.60 ± 0.79	3.73 ± 0.82	3.56 ± 1.01	3.56 ± 0.77	3.43 ± 0.85
Creatinine	65.08 ± 11.70	64.26 ± 12.52	66.05 ± 13.00	60.06 ± 8.22	62.03 ± 10.84	59.17 ± 10.02	58.94 ± 12.30	61.83 ± 13.22	59.89 ± 13.32
eGFR	99.24 ± 14.35	100.13 ± 14.03	98.76 ± 14.83	104.43 ± 8.57	101.86 ± 11.74	105.51 ± 9.79	105.86 ± 12.62	101.75 ± 14.45	104.58 ± 13.09
Uric acid	0.30 ± 0.06	0.30 ± 0.06	0.30 ± 0.05	0.29 ± 0.05	0.28 ± 0.06	0.28 ± 0.06	0.28 ± 0.06	0.29 ± 0.06	0.28 ± 0.07
Calcium	2.27 ± 0.08	2.25 ± 0.08	2.26 ± 0.08	2.32 ± 0.08	2.29 ± 0.11	2.27 ± 0.08	2.29 ± 0.08	2.27 ± 0.08	2.24 ± 0.09
Phosphate	1.11 ± 0.18	1.13 ± 0.16	1.25 ± 0.43	1.15 ± 0.17	1.16 ± 0.16	1.28 ± 0.52	1.08 ± 0.17	1.10 ± 0.15	1.18 ± 0.46
Total protein	75.40 ± 3.66	74.84 ± 2.63	74.71 ± 3.25	75.54 ± 4.08	74.26 ± 3.24	73.40 ± 3.04	75.78 ± 3.80	74.92 ± 3.57	73.97 ± 3.60
Albumin	44.53 ± 2.62	43.90 ± 2.35	44.21 ± 1.71	44.94 ± 2.30	44.80 ± 2.90	44.49 ± 2.25	44.78 ± 1.88	44.92 ± 2.43	44.81 ± 2.41
Globulin	30.87 ± 3.32	30.95 ± 3.11	30.50 ± 2.76	30.60 ± 3.30	29.46 ± 3.33	28.91 ± 2.76	31.00 ± 2.87	30.00 ± 3.63	29.17 ± 2.97
Alkaline phosphatase	77.26 ± 26.84	78.82 ± 48.10	74.50 ± 19.22	73.63 ± 18.26	70.83 ± 17.94	72.06 ± 20.16	68.22 ± 12.74	66.11 ± 12.39	67.42 ± 14.98
Total bilirubin	8.58 ± 2.84	8.58 ± 2.33	8.71 ± 3.15	9.83 ± 4.59	9.66 ± 5.14	9.91 ± 4.33	8.97 ± 3.38	9.03 ± 3.44	8.39 ± 2.98
GGT	34.74 ± 36.10	34.84 ± 44.10	33.90 ± 27.06	25.77 ± 15.65	24.80 ± 17.52	24.94 ± 14.72	27.64 ± 25.97	24.06 ± 18.53	25.56 ± 28.09
ALT	26.32 ± 32.76	27.50 ± 45.75	22.03 ± 15.88	18.89 ± 15.45	18.06 ± 14.55	19.57 ± 12.61	19.78 ± 14.29	19.42 ± 13.90	19.39 ± 13.26
C-Reactive Protein	3.58 ± 2.84	3.07 ± 2.23	4.05 ± 3.77	2.37 ± 2.11	2.92 ± 3.37	3.09 ± 3.33	2.71 ± 2.13	2.38 ± 1.71	3.65 ± 3.81
Total cholesterol	5.72 ± 1.26	5.78 ± 1.10	5.73 ± 1.07	5.77 ± 0.93	5.47 ± 0.82	5.43 ± 0.81	5.60 ± 0.75	5.60 ± 0.77	5.59 ± 0.84
Triglyceride	1.32 ± 1.02	1.22 ± 0.77	1.32 ± 0.99	1.05 ± 0.38	1.35 ± 1.59	0.98 ± 0.32	1.15 ± 0.49	1.09 ± 0.59	1.16 ± 0.52
HDL cholesterol	1.61 ± 0.41	1.58 ± 0.36	1.63 ± 0.41	1.68 ± 0.35	1.61 ± 0.33	1.64 ± 0.32	1.68 ± 0.42	1.61 ± 0.34	1.60 ± 0.32
LDL cholesterol	3.58 ± 1.03	3.63 ± 1.08	3.48 ± 1.07	3.61 ± 0.96	3.37 ± 0.80	3.33 ± 0.85	3.40 ± 0.73	3.49 ± 0.72	3.46 ± 0.85
Non-HDL cholesterol	4.11 ± 1.14	4.19 ± 1.06	4.10 ± 1.05	4.09 ± 1.06	3.86 ± 0.88	3.78 ± 0.91	3.93 ± 0.79	3.99 ± 0.82	3.99 ± 0.93
Total cholesterol/HDL	3.73 ± 1.10	3.80 ± 1.00	3.71 ± 1.10	3.60 ± 1.06	3.55 ± 0.93	3.45 ± 0.98	3.53 ± 0.89	3.61 ± 0.89	3.63 ± 0.93
Hormone profile
Progesterone	15.47 ± 10.11	12.95 ± 10.16	15.15 ± 9.23a	18.21 ± 11.80	20.09 ± 12.94	16.03 ± 15.47a	13.33 ± 7.10	19.14 ± 11.58b	19.05 ± 10.50a
Serum testosterone	0.45 ± 0.27	0.49 ± 0.30	0.51 ± 0.36	0.67 ± 0.54	0.65 ± 0.46	0.64 ± 0.48	0.61 ± 0.35	0.69 ± 0.36	0.57 ± 0.34
Follicle stimulating hormone	25.66 ± 27.96	22.18 ± 26.13	22.91 ± 26.52	35.18 ± 34.78	35.25 ± 35.52	30.87 ± 32.03	30.13 ± 30.14	29.89 ± 31.10	28.39 ± 32.47
Luteinizing hormone	15.06 ± 15.29	16.28 ± 18.04	18.79 ± 21.44	25.16 ± 20.66	24.68 ± 23.19	22.71 ± 20.24	20.17 ± 17.03	22.48 ± 16.68	18.93 ± 15.99
Estradiol	357.39 ± 472.23	433.14 ± 388.06	424.91 ± 279.29	435.48 ± 392.41	323.45 ± 312.32	470.97 ± 565.94	328.50 ± 331.87	546.54 ± 622.99	385.71 ± 401.61

^aP < 0.05 mean difference between placebo, Physta^® 50 mg and Physta^® 100 mg at baseline.

^bP < 0.05 mean changes between Physta^® 100 mg and placebo.

Data are presented as the mean ± SD scores for biochemical parameters across placebo, Physta^® 50 mg, and Physta^® 100 mg groups at baseline, week 6, and week 12. Mixed analysis of variance was used for time-by-group effects, and independent t-tests for between-group comparisons. BMI: Body mass index; SBP: Systolic blood pressure; DBP: Diastolic blood pressure; eFGR: Estimated glomerular filtration rate; GGT: Gamma-glutamyl transferase; ALT: Alanine transaminase; HDL: High-density lipoprotein; LDL: Low-density lipoprotein.